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Biofrontera Bioscience GmbHEU/1/11/740/001

Main Information

Trade NameAmeluz
Active Substances5-aminolevulinic acid hydrochloride
Dosage FormGel
Licence HolderBiofrontera Bioscience GmbH
Licence NumberEU/1/11/740/001

Group Information

ATC CodeL01XD Sensitizers used in photodynamic/radiation therapy
L01XD04 aminolevulinic acid


License statusAuthorised
Licence Issued14/12/2012
Legal statusProduct subject to prescription which may not be renewed (A)
Supply StatusSupply through pharmacies only
Advertising StatusAdvertising to healthcare professionals only
Conditions of LicenceMedicinal product subject to restricted medical prescription (see Annex I: Summary of Product Characteristics, section 4.2).
Marketing StatusUnknown


Summary of Product CharacteristicsSearch EMA website
Package LeafletSearch EMA website
Public Assessment ReportSearch EMA website
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